Z-1238-2019 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 8, 2019
- Initiation Date
- January 10, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 79 kits (none in US, all in ROW)
Product Description
AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
Reason for Recall
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
Distribution Pattern
Worldwide distribution - US Nationwide distribution. and countries of Austria, Bolivia, UK, Switzerland,Thailand, Finland.
Code Information
Kit Lot Numbers: 664670, 666553 Pack Lot Numbers: 1066467001, 1066467002, 1066655301 UDI: (01)06438147009336(17)190430(10)664670 (01)06438147009336(17)190430(10)666553